A Multicenter Randomized Phase II Study of First Line Treatment With Sequential Administration of Docetaxel, Carboplatin and Herceptin Versus the Administration of Vinorelbine and Herceptin Combination in HER-2 Positive Patients With Metastatic Breast Cancer
18 Years
75 Years
Female
Breast Cancer
Trial Information
A Multicenter Randomized Phase II Study of First Line Treatment With Sequential Administration of Docetaxel, Carboplatin and Herceptin Versus the Administration of Vinorelbine and Herceptin Combination in HER-2 Positive Patients With Metastatic Breast Cancer
Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the
transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of
women with HER2-positive metastatic breast cancer. The combination of Herceptin and
chemotherapy yielded significantly better results than chemotherapy alone in response, time
to progression, and survival time. Whether the combination of Docetaxel, Carboplatin and
Herceptin versus the administration of Vinorelbine and Herceptin combination in HER-2
positive patients with metastatic breast cancer is preferable is not yet known.
Inclusion Criteria:
- Performance status (WHO) 0-2
- Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any
prior chemotherapy received
- HER-2 overexpression 2+ or 3+ using IHC or FISH +
- Measurable disease not in a prior irradiation field (no other concurrent chemotherapy
agents)
- No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since
prior radiotherapy and recovered)
- More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered
- No prior first line chemotherapy for metastatic disease
- Endocrine therapy is allowed as adjuvant or first line treatment for metastatic
disease
- Paraffin block from the primary tumor available in the research lab
- Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count
> 100000/mm^3, hemoglobin > 9 gr/mm^3)
- Adequate liver (Bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times
upper limit of normal) and renal function (creatinine < 2mg/dl)
- Adequate cardiac function (LVEF > 50%)
- Informed consent
Exclusion Criteria:
- Pregnant or nursing
- Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce
P-450 cytochrome
- Positive pregnancy test
- Motor or sensory neuropathy > grade 1 according to NCIC Τoxicity Criteria
- Patients with brain metastatic disease who has not been irradiated or uncontrolled
brain metastatic disease after irradiation
- History of allergic reaction attributed to docetaxel
- Psychiatric illness or social situation that would preclude study compliance
- Other concurrent uncontrolled illness.
- Other invasive malignancy within the past 5 years except cured basal cell skin
carcinoma and cervical carcinoma in situ
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression between the two treatment arms
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Dimitris Mavroudis, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital of Crete, Dep of Medical Oncology
Authority:
Greece: National Organization of Medicines
Study ID:
CT/03.08
NCT ID:
NCT00453635
Start Date:
December 2003
Completion Date:
November 2008
Related Keywords:
- Breast Cancer
- Cancer
- Breast cancer
- First line treatment
- Docetaxel
- Carboplatin
- Herceptin
- Vinorelbine
- Breast Neoplasms
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